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NCT Number: NCT05040139

A Comparison of Quality of Life Between MAlone Procedure and Percutaneaous Endoscopic Caecostomy in Patients With Antegrade Colonic Enema

Background: Antegrade colonic enema (ACE) is a second intent treatment of severe constipation and/or fecal incontinence following the failure of medical treatment. ACE is classically administered through a percutaneous access to the caecum performed surgically according to the Malone procedure (MP). Recently, a novel endoscopic approach named Percutaneous Endoscopic Caecostomy (PEC) has been proposed to perform the percutaneous access to the caecum. PEC has never been compared to the traditional MP in terms of postoperative quality of life and functional outcomes.

Objective: The aim of the study is to compare postoperative quality of life between MP and PEC in patients treated with ACE for severe constipation and/or fecal incontinence.

Hypothesis: MP and PEC achieve similar quality of life outcomes. Methods: All patients from two prospective databases who underwent MP or PEC for severe constipation and/or fecal incontinence between 2006 and 2016 will be included. They will be contacted to answer questionnaires about quality of life (GIQLI) and functional outcomes including constipation, fecal incontinence and body image assessment (KESS, Wexner and BIQ scores respectively). The main measured outcome will be GIQLI score.

Results: The results of this comparative study will determine if the endoscopic and the surgical approaches are similar in terms of quality of life, or if one of them is better than the other. This study will clarify the optimal protocol to perform a caecal percutaneous access before ACE administration in patients suffering from severe constipation and/or fecal incontinence.

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Key information

Conditions

Constipation Aggravated Constipation Digestive System Diseases Fecal Incontinence Fecal Incontinence With Fecal Urgency Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, Loire-Atlantique, 44000, France

About this study

Background: Antegrade colonic enema (ACE) is a second intent treatment of severe constipation and/or fecal incontinence following the failure of medical treatment. ACE is classically administered through a percutaneous access to the caecum performed surgically according to the Malone procedure (MP). Recently, a novel endoscopic approach named Percutaneous Endoscopic Caecostomy (PEC) has been proposed to perform the percutaneous access to the caecum. PEC has never been compared to the traditional MP in terms of postoperative quality of life and functional outcomes.

Objective: The aim of the study is to compare postoperative quality of life between MP and PEC in patients treated with ACE for severe constipation and/or fecal incontinence.

Hypothesis: MP and PEC achieve similar quality of life outcomes. Study design: All patients from two prospective databases who underwent MP or PEC for severe constipation and/or fecal incontinence between 2006 and 2016 will be included. They will be contacted by mail to answer questionnaires about quality of life (GIQLI) and functional outcomes including constipation, fecal incontinence and body image assessment (KESS, Wexner and BIQ scores respectively). Patients who did not answer to the mail will be phoned. The collection of patients' answers will be conducted over a 3 months period.

Main outcome measures: Quality of life evaluated by the GIQLI score. Secondary outcomes measures: Functional outcomes including constipation severity (measured by the KESS score), fecal incontinence severity (measured by the Wexner score), body image impairment (measured by the BIQ score).

Results: The results of this comparative study will determine if the endoscopic and the surgical approaches are similar in terms of quality of life, or if one of them is better than the other. This study will clarify the optimal protocol to perform a caecal percutaneous access before ACE administration in patients suffering from severe constipation and/or fecal incontinence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe constipation and/or severe incontinence refractory to medical treatment.

Exclusion criteria

  • Malone procedure or percutaneous endoscopic caecostomy between 2006 and 2016

Treatment and study plan

Malone Procedure

Procedure

Surgical procedure performed to obtain a percutaneous caecal access for the administration of antegrade colonic enemas. Briefly, the procedure is performed under general anesthesia. The surgeon bring the end of the appendix (or a tubulized segment of the ileum) out through the abdominal wall. The appendix is opened and sutured to the abdominal skin.

Percutaneous endoscopic caecostomy

Procedure

Endoscopic procedure performed to obtain a percutaneous caecal access for the administration of antegrade colonic enemas. Briefly, a coloscopy is performed to reach the caecum. The cutaneous location of the caecostomy is determined by transillumination of the caecum. A caecopexy is performed with 3 anchors at the chosen location. A specific pig-tail catheter (Chait catheter) is placed percutaneously into the caecum in the center of the 3 anchors.

Primary outcomes

  1. Comparison of the quality of life of patients treated with anterograde colonic enemas after Malone surgical technique and percutaneous endoscopic caecostomy.

    Time frame: one year

    Quality of life evaluated by the GastroIntestinal Quality of Life score (GIQLI).

    The GIQLI (GastroIntestinal Quality of Life) questionnaire consists of 36 questions giving a global quality of life score and 5 sub-scores (digestive symptoms, physical scale, mental scale, social scale and effects of drug treatments).

Secondary outcomes

  1. constipation

    Time frame: one year

    Constipation will be evaluated by the Kess constipation severity score. The Kess questionnaire consists of 11 questions assessing the symptoms of constipation and giving a single score.

  2. anal incontinence

    Time frame: one year

    Anal incontinence will be evaluated with the WEXNER score.

    • The Wexner questionnaire consists of 5 questions evaluating the symptoms of incontinence and giving a single score.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

A Comparative Study Between Malone Procedure and Percutaneaous Endoscopic Caecostomy in Patients Treated With Antegrade Colonic Enema for Severe Anal Incontinence and/or Constipation

Acronym: MAPEC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2021
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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